Brand Name(s):

Nuvigil®

WHY is this medicine prescribed?

Armodafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Armodafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore does not get enough restful sleep). Armodafinil is in a class of medications called wakefulness-promoting agents. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.

HOW should this medicine be used?

Armodafinil comes as a tablet to take by mouth. It is usually taken once a day. If you are taking armodafinil to treat narcolepsy or OSAHS, you will probably take it in the morning. If you are taking armodafinil to treat shift work sleep disorder, you will probably take it 1 hour before the start of your shift. Take armodafinil at around the same time every day. Do not change the time of day that you take armodafinil without talking to your doctor. Talk to your doctor if your work shift does not begin at the same time every day. Follow the directions on your prescription label carefully, and ask our doctor or pharmacist to explain any part you do not understand. Take armodafinil exactly as directed.

Armodafinil may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Armodafinil may decrease your sleepiness, but it will not cure your sleep disorder. Continue to take armodafinil even if you feel well-rested. Do not stop taking armodafinil without talking to your doctor.

Armodafinil should not be used in place of getting enough sleep. Follow your doctor's advice about good sleep habits. Continue to use any breathing devices or other treatments that your doctor has prescribed to treat your condition, especially if you have OSAHS.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking armodafinil,

tell your doctor and pharmacist if you are allergic to armodafinil, modafinil (Provigil) or any other medications.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); clomipramine (Anafranil); cyclosporine (Gengraf, Neoral, Sandimmune); diazepam (Valium); erythromycin (E.E.S., E-Mycin, Erythrocin); ketoconazole (Nizoral); omeprazole (Prilosec, in Zegerid); certain medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); midazolam; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); propranolol (Inderal); rifampin (Rifadin, Rimactane, in Rifamate); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with armodafinil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever had chest pain, an irregular heartbeat, or other heart problems after taking a stimulant, and if you have or have ever had a heart attack; chest pain; high blood pressure; a mental illness such as depression, mania (frenzied, abnormally excited mood), or psychosis (difficulty thinking clearly, communicating, understanding reality, and behaving appropriately); or heart, liver,or kidney disease.

you should know that armodafinil may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). Use another form of birth control while you are taking armodafinil and for 1 month after you stop taking it. Talk to your doctor about types of birth control that will work for you during and after your treatment with armodafinil.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking armodafinil, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking armodafinil.

you should know that armodafinil may affect your judgment, thinking and movement, and may not completely relieve the sleepiness caused by your disorder. Do not drive a car or operate machinery until you know how this medication affects you. If you avoided driving and other dangerous activities because of your sleep disorder, do not start performing these activities again without talking to your doctor even if you feel more alert.

be aware that you should avoid drinking alcohol while you are taking this medication.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Armodafinil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache

dizziness

difficulty falling asleep or staying asleep

difficulty concentrating or paying attention

uncontrollable shaking of a part of the body

numbness, burning, or tingling of the hands or feet

nausea

vomiting

heartburn

stomach pain

constipation

diarrhea

loss of appetite

thirst

dry mouth

sweating

frequent urination

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

Armodafinil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store armodafinil in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

agitation

difficulty falling asleep or staying asleep

restlessness

disorientation

confusion

hallucinating (seeing things or hearing voices that do not exist)

nausea

diarrhea

fast or slow heartbeat

chest pain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Selling or giving away armodafinil is against the law. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.

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